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Seare Biomedical Nasal Implants are intended for use in augmentation and reconstruction of the nasal contour during rhinoplasty. They are intended for insertion via an intraoral or nasal sill incision.

"L" shaped or straight with a concave convex dorsal aspect which reaches from the alar cartilage to the radix. These silicone rubber implants are made from specially formulated silicone elastomers designed for implantation. Surface characteristics will vary from smooth to varying degrees of texturing and porosity. Seare Biomedical Nasal Implants are intended for use in augmentation of the nasal contour during thinoplasty. They are intended for insertion via an intraoral or nasal sill incision. The Seare Biomedical Nasal Implants will be available in many sizes and styles, all of which are very similar - differing only by a few millimeters in length and projection. The Seare Biomedical Nasal Implants will be provided sterile. Thanium Oxide and Iron Oxide pigments may be added to the silicone to prevent light translucence to these implants when ordered by the physician. These pigments are well known and widely used in cosmetic surgery implant applications, and will be lot tested for cytotoxicity.

The provided text is a 510(k) Summary for a medical device called "Seare Biomedical Nasal Implants." It does not contain information about acceptance criteria or a study proving that the device meets such criteria in the way typically associated with performance evaluations of AI/ML-based medical devices.

Instead, this document focuses on establishing substantial equivalence to a predicate device based on material, function, performance, and design, as well as identical indications for use.

Here's an analysis based on your requested information categories:

1. A table of acceptance criteria and the reported device performance

   • Acceptance Criteria: Not explicitly stated as performance metrics. The implicit "acceptance criteria" for a 510(k) submission of this type is substantial equivalence to a predicate device.
   • Reported Device Performance: No specific performance metrics (e.g., sensitivity, specificity, accuracy, precision) are reported because the device is a passive implant, not a diagnostic or AI-powered system that generates numerical results. The performance is deemed equivalent to the predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • No test set was used for this type of evaluation. The submission states "Clinical Tests: None." This indicates that no human subject data was collected or analyzed for this 510(k) clearance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   • Not applicable. No test set or ground truth establishment by experts was performed for this 510(k) submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   • Not applicable. No test set required adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

   • No MRMC study was done. This device is a silicone nasal implant, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

   • Not applicable. The device is a physical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

   • Not applicable. No ground truth measurements were described or required for this type of device clearance.

8. The sample size for the training set

   • Not applicable. This device is not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

   • Not applicable. No training set or ground truth establishment was involved.

In summary, the provided document is a 510(k) submission for a traditional medical device (nasal implants) based on substantial equivalence, not a performance study for an AI/ML-powered device. Therefore, most of the requested information regarding acceptance criteria, test sets, experts, and AI-related studies is not present or applicable.

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